Nanoform Q1 2025 report: Deal mosaic emerge and commercial value clearly seen in our CESS® technology

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1-3/2025 key financials

• Revenue grew by 46% to EUR 0.9 million, compared with EUR 0.6 million in 1Q24.
• The gross profit grew to EUR 0.7 million, with the gross margin rising to 82% (EUR 0.5 million, 80%).
• Total operating costs* fell by -4% to EUR 6.2 million (EUR 6.5 million).
• The number of employees grew by 8% to 179 (166) compared with one year ago.
• EBITDA improved to EUR -4.9 million (EUR -5.7 million).
• The operating free cash flow improved to EUR -5.2 million (EUR -6.0 million).
• Basic EPS was EUR -0.06 (EUR -0.09).
• Cash position** was 37.0 million on March 31, 2025 (EUR 41.3 million)

<sup>(Numbers in brackets refer to the corresponding last year reporting period, unless otherwise mentioned.)
* Defined as materials & services expenses, employee benefit expenses, and other operating expenses.
** Including Treasury bills. Part of the cash has been invested in short-term government bonds.</sup>

Significant events during 1-3/2025

• In January our R&D team further scaled-up the CESS® technology by a factor 20x on nanoenzalutamide, indicating that after tech-transfer into GMP, we will be ready for the estimated 1000kg+ commercial demand when launched globally. This technology development also support the commercial needs of nanoapalutamide and nanoencorafenib.
• On February 27, 2025 Nanoform announced that dealmaking discussions around product kernels have intensified and that the company expect to sign deals on the first three product kernels (nanoenzalutamide, nanoapalutamide and nanoencorafenib) in coming weeks and months.
• In March, a new US global major pharma company was signed.
• At the end of March we filed for a commercial license for nanoenzalutamide to Fimea.
• In March a lead investor signed a term sheet around nanoencorafenib.
• During the quarter we successfully implemented and went live with TrackWise eQMS (digital quality management system).
• Nanoform has earlier filed patent applications for its small molecule controlled crystallization platform that produces crystalline polymer embedded nanoparticles (cPENs^TM). We are very pleased that the first patent family member was recently granted in the United States by the USPTO. This is evidence for the significant opportunity Nanoform has to generate valuable IP leveraging its platforms for nanoformulations and products. The cPEN^TM formulation platform is utilized for nanoenzalutamide, nanoapalutamide, and nanoencorafenib, among other internal and ongoing customer projects.

Significant events after 1-3/2025

• Nanoform’s AGM was held on April 15, 2025. 42 shareholders representing 58.9% of all outstanding shares and votes were represented at the meeting. All proposals by the Board were approved. The AGM approved the financial statements and discharged the Board of Directors and the CEO from liability for the financial year 2024. The meeting decided that no dividend will be paid for the financial year and authorized the Board to repurchase the company’s own shares and to decide on the issuance of shares as well as special rights entitling to shares. The meeting approved the proposals regarding the members of the Board of Directors and their remuneration. The AGM further resolved the number of members of the Board of Directors to be three and the AGM re-elected Miguel Calado (Chairperson), Albert Hæggström and Jeanne Thoma as ordinary members of the Board of Directors.
• In April, Nanoform won a new grant from the Gates Foundation to work on several of the foundation’s drug development projects.
• In April, our Bio R&D team achieved a 10x scale-up of our Biologics technology, by producing 2kg in one continuous run on our pilot GMP line. This supports our efforts to show the commercial value the technology can bring to the fast-growing field of high-concentration subcutaneous injections of monoclonal antibodies (mAbs).
• In April we successfully concluded our GMP campaign of nanoenzalutamide. 100kg material was produced and shipped to Bluepharma, where hundreds of thousands of tablets are being produced. This successful campaign has resulted in a validated process for nanoenzalutamide. This supports our upcoming regulatory filing.
• Takeda has informed Nanoform that they plan to present results related to their project with Nanoform’s Biologics technology at the Drug Delivery Forum in Berlin in the beginning of June.

CEO’s review

Let me start with the question investors ask us. How is the dealmaking going? After six quarters of technology, IP and formulation discussions with dozens of companies around the world, we are finally seeing the full mosaic of many license and supply agreements for the planned global launch of nanoenzalutamide start to emerge. We have in place agreed term sheets for several of the most important markets and the message is clear. Our commercialization partners are excited about the technology, the IP advantages, patient, sustainability & cost benefits and hence see significant commercial value in what Nanoform’s CESS® technology can offer. Based on term sheets for several key markets like the US, Japan, Germany and France, we see that the total potential value the nanoenzalutamide project could bring to us and our ONConcept partners is EUR 10m+ in potential development milestones up until launch, EUR 25m+ in potential commercial milestones and significant profit share after launch if the sales and market share estimates we have received from our future commercialization partners are realized. Combined annual peak sales of nanoenzalutamide could exceed 1000kg even with potentially somewhat conservative estimates.

Manufacturing of 100kg of GMP material in project Nanoenzalutamide was concluded in 1Q25 and our partner Bluepharma in Portugal has now made hundreds of thousands of tablets for the upcoming pivotal studies and registration batches. The scale-up from the pilot study a year ago was close to 100x and on the R&D side we have already demonstrated a further 20x improvement in the production rate, which lays a path for nanoforming to become also a cost leader compared with other technologies in the coming years.

We expect nanoenzalutamide to be the first nanoformed medicine to reach the market – with a planned launch in 2027/28 in the US/EU – and to be an income driver for Nanoform already in the upcoming years. Nanoenzalutamide is expected to progress via the ANDA*/Hybrid generic pathway and as such will need to show bioequivalence vs the originator product, Xtandi®. In the eyes of the regulators, bioequivalence means 80% – 125% of the Cmax and AUC in a large cohort study in fed and fasted states with a 90% confidence interval.* ANDA=Abbreviated New Drug Application
The global annual sales of Xtandi® is presently USD 6bn and growing. We plan for nanoenzalutamide to take a meaningful share of this market through its highly patient centric product differentiation (1 tablet vs 4 tablets) and unique IP position (different technology, crystalline product, different excipients), while not forgetting its green attributes. We see the program to be attractive to value added medicine companies as a uniquely differentiated and high value supergeneric product that can enable a product launch before market entry by other generic products based on the ASD formulation, for which the originator currently holds patents in both Europe and the US (with expiry dates in 2033). For the originator company we believe that the nanocrystalline single tablet product offers a patient centric life cycle extension opportunity with compelling sustainability advantages that would be difficult for generic competitors to match. Avoiding the inherent stability challenges associated with amorphous materials is also a clear benefit for any company considering alternative formulation approaches.

Xtandi®-tablets are formulated using a solubility-enhancement spray drying process to create an amorphous solid dispersion. The major challenge with spray drying is that the process often requires large amounts of undesirable and toxic organic solvents. Nanoform’s CESS® process uses CO2 of recycled origin, and is organic solvent-free, offering a greener alternative to medicine developers that seek to be both patient- and planet-centric. Nanoform continuously improves the CESS® technology, e.g. by planning to further recycle the CO2 used by the process to become a carbon sink. This is an attractive proposition for the pharma industry to achieve its ambitious net zero goals. There are already concerns in the industry that industrial approaches with a heavy carbon footprint, e.g. spray drying, may lose their relevance in the future because of their environmental burden.
The timelines for the commercial launch of nanoenzalutamide are demanding, but achievable. We have now manufactured nanoformed GMP material for the registration batches and the pivotal bioequivalence studies. When positive, the submissions of the dossiers will follow, with the aimed product launch after the expiry of the enzalutamide substance patent in the respective territories (2027/28, US/EU).

The deal negotiations around our other product kernels (nanoapalutamide and nanoencorafenib) are also progressing well, and we expect to sign deals with development partners and commercialization partners in the coming months and quarters.

During the past year we have worked on more than 40 different customer projects. These cover both small molecules and biologics, and range across multiple therapy areas and delivery methods. I remain encouraged by the diversity of our nanoparticles and nanoformulations. Not all customer projects progress – for a whole host of reasons – but the momentum I see in many of these projects makes me confident that we will also see some of these ongoing customer projects enter the clinic in the upcoming quarters and years. This also serves as testament to our strategy to work with many different companies and APIs, and not become dependent on any single project.

For Nanoform the last years have been about making large investments and building a capable organization. The coming will be about preparing to launch nanoformed products together with partners onto the global markets. We are ready for the challenge. I look forward with confidence and excitement to the coming years. None of this can be done without our amazing employees and great partners. My sincere THANK YOU to you all for your continued dedication to Nanoform and for the inspiring and innovative work for which we’re known.

Best Regards,
Prof. Edward Hæggström, CEO Nanoform

Company near-term business targets for 2025

• To sign development and license/commercial supply agreements on several product kernels during 2025
• First pivotal bioequivalence study with nanoformed medicine
• Increased number of non-GMP and GMP projects signed in 2025 vs 2024
• Improved free cash flow in 2025 vs 2024

Company mid-term business targets 2030

• To be announced during 2025 in conjunction with Capital Markets Day.

Nanoform’s Q1 2025 report and management presentation can be found at: https://nanoform.com/en/financial-reports-and-presentations/

Nanoform online presentation and conference call May 20^th, 2025, at 3:00 p.m. Helsinki time / 2:00 p.m. Stockholm time:

Nanoform will be represented by CEO Edward Hæggström, CFO Albert Hæggström, General Counsel/CDO Peter Hänninen, and CCO Christian Jones. The presentation will be delivered in English.

The presentation will be broadcasted live and participants may access the event via audiocast and teleconference through the following link:

https://investorcaller.com/events/nanoform/nanoform-q1-report-2025

To participate in the event, attendees are required to register. To join the Q&A session, attendees must access the teleconference by dialing in. Upon registration, participants will receive a dial-in number, a conference ID, and a personal User ID to access the conference. Please note that questions can only be submitted through the teleconference line.

For further information, please contact:

Dr. Edward Hæggström, CEO
Edward.haeggströn@nanoform.com
+358 (0)29 370 0150

Henri von Haartman, Director of Investor Relations
hvh@nanoform.com
+46 (0)7686 650 11

About Nanoform
Nanoform is the medicine performance-enhancing company that leverages best-in-class innovative nanoparticle engineering technologies, expert formulation, and scalable GMP API manufacturing to enable superior medicines for patients. The company focuses on reducing clinical attrition and on enhancing drug molecules’ performance through its nanoforming technologies and formulation services, from pre-formulation to commercial scale. Nanoform will help improve bioavailability and drug delivery profiles, drive differentiation, patient adherence and extend the lifecycle potential of products. Nanoform’s shares are listed on the Premier-segment of Nasdaq First North Growth Market in Helsinki (ticker: NANOFH) and Stockholm (ticker: NANOFS). Certified Adviser: DNB Carnegie Investment Bank AB, +46 (0)73 856 42 65, certifiedadviser@carnegie.se. For more information, please visit www.nanoform.com.

Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements regarding Nanoform’s strategy, business plans and focus. The words “may”, “will”, “could”, “would”, “should”, “expect”, “plan”, “anticipate”, “intend”, believe”, “estimate”, “predict”, “project”, “potential”, “continue”, “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Nanoform’s business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other companies, and other risks described in the Report of the Board of Directors and Financial Statements for the year ended December 31, 2024 as well as our other past disclosures. Nanoform cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Nanoform disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Nanoform’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.